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Abstract:

A method for the production of antibodies or microbial adherents
administers is disclosed. The antibodies or microbial adherents
inhibitors are administered to a patient suffering from strep throat to
substantially prevent the adherents of colony-forming immunogens or
haptens in the throat of the patient. Application of the antibodies
should decrease the colonization of the oropharnyx, and therefore
decrease symptoms of the sore inflamed throat and ultimately decrease the
need for antibiotics.

Claims:

1. A method of production of an adherence inhibitor for administration to
humans to control the colonization of Streptococcus bacteria by
preventing the adherence of the Streptococcus bacteria to a surface of a
membrane or organ within the human, the method comprises:a. inoculating
female birds, in or about to reach their egg laying age, with a
Streptococcus bacteria;b. allowing a period of time sufficient to permit
the production in the birds of antibody to the Streptococcus bacteria;C.
harvesting the eggs laid by the birds; andd. separating the
antibody-containing contents of said eggs from the shells.

5. The method of claim 3 including:providing a dried material, said drying
of the separated antibody-containing contents of said eggs is achieved by
drying the separated antibody-containing contents of said eggs.

6 The method of claim 5 wherein:the material is a liquid product achieved
by using separated antibody-containing contents of said eggs.

7. A treatment of a Streptococcus bacterial infection, the treatment
comprising:administering an antibody specific to an adheren of the
Streptococcus bacteria that causes adhesion to a membrane or organ.

8. The treatment of claim 7 wherein the antibody specific to the adheren
of the Streptococcus bacteria is produced by:a. inoculating female birds,
in or about to reach their egg laying age, with a Streptococcus
bacteria;b. allowing a period of time sufficient to permit the production
in the birds of antibody to the Streptococcus bacteria;C. harvesting the
eggs laid by the birds; andd. separating the antibody-containing contents
of said eggs from the shells.

12. A method for substantially reducing or eliminating the incidents of
Streptococcus bacteria by inhibiting the ability of the Streptococcus
bacteria to adhere to a surface of a membrane or organ thereby reducing
the ability of the Streptococcus bacteria to colonize and multiply, the
method comprising:administering an antibody specific to an adheren of the
Streptococcus bacteria that causes adhesion to a membrane or organ.

13. The treatment of claim 12 wherein the antibody specific to the adheren
of the Streptococcus bacteria is produced by;a. inoculating female birds,
in or about to reach their egg laying age, with a Streptococcus
bacteria;b. allowing a period of time sufficient to permit the production
in the birds of antibody to the Streptococcus bacteria;c. harvesting the
eggs laid by the birds; andd. separating the antibody-containing contents
of said eggs from the shells.

Description:

CROSS-REFERENCE TO RELATED APPLICATION

[0001]The present application is based on and claims the benefit of U.S.
provisional patent application Ser. No. 60/856,096, filed Nov. 2, 2006,
the content of which is hereby incorporated by reference in its entirety.

BACKGROUND OF THE INVENTION

[0002]Streptococcus is a genus of spherical, Gram-positive bacteria that
are known to be the primary cause of throat infections. Streptococcal
sore throat, or strep throat as it is more commonly called, is an
infection of the mucous membranes lining the pharynx. Sometimes the
tonsils are also infected (tonsillitis).

[0003]Streptococcus is also a concern due to the development of not only
throat infections, but also due to the other sequella of the infection,
namely rheumatoid heart disease. This is where the organism invades the
blood stream and causes vegetations on the heart valves. Streptococcus is
one of the most frequent causes for visits to the doctor's office in the
United States. It is also one of the most frequent reasons for antibiotic
use.

[0004]The number of people with sore throats in the United States that
seek medical attention is an estimated 120 million visits per year.
Approximately 12 to 25 percent of those individuals have positive strep
cultures. Far more individuals than those diagnosed with strep throat are
placed on antibiotics because there is no other available treatments.

[0005]The large numbers of people that are prescribed antibiotics for this
illness helps to increase the incidence of resistant bacteria as observed
in rising levels of antibiotic resistant infections in the public.
Antibiotics that were once almost universally effective against these
infections are now approximately 70 to 80% effective. This trend is more
prevalent in certain parts of the country and continued increases are
expected due to widespread use of antibiotics to treat these very common
infections.

[0006]It has been discovered that use of antibodies that specifically
attack the microorganisms responsible for strep throat are useful in
reducing the progression of this illness. Accordingly, the present
invention is directed to microbial adherence inhibitors or antibodies for
substantially preventing the attachment or adherence of colony-forming
immunogens or haptens of Streptococcus that are present during the
initiation and or progression of strep throat.

[0007]A principal objective of the present invention is to substantially
prevent the colonization of Streptococcus species, as well as the growth
of such organisms resulting in their substantial elimination from an
individual.

[0008]Haptens are partial or incomplete immunogens such as certain toxins,
which cannot by themselves cause antibody formation but are capable of
combining with specific antibodies. Such haptens may include bacterial
toxin, yeast mold toxin, viruses, parasite toxins, algae toxins, etc.

[0009]Members of the Streptococcus genus are responsible for the
occurrence of strep throat, meningitis, bacterial pneumonia, endocarditis
(inflammation of the inner layer of the heart), erysipelas (bacterial
skin infection) even necrotizing, and fascitis (a rare infection of the
deeper layers of skin and subcutaneous tissue commonly known as
flesh-eating bacteria infection).

[0010]Individual species of this genus of interest in this application
include the following S. agalactiae, S. bovis, S. mutans, S. pneumoniae,
S. pyogenes, S. sanguinis, S. suis, and S. viridans.

[0011]Streptococcus species have been characterized into groups identified
by "A" to "O". Groups A and B (also known as "Group A strep" and "Group B
strep") are the most important based on causing common diseases in
humans.

[0012]S. pyogenes is the causative agent in Group A for Streptococcal
infections including strep throat, acute rheumatic fever, scarlet fever
and acute glomerulonephritis (inflation of the glomeruli). Other
Streptococcus species may also possess the Group A antigen.

[0013]S. agalactiae is a primary causative agent in Group B Streptococcal
infections and causes meningitis and neonates in the elderly with
occasional systemic bacteremia. S. agalactiae can also colonize in the
female reproductive tract. For females who are pregnant, antibiotics are
not recommended due to the risk benefit. Therefore this infection goes
untreated.

[0014]Group D strains of Streptococcus include S. bovis and S. suis. S.
bovis is occasionally found to be the causative agent in cases of human
endocarditis and also sometimes a rare cause of neonatal septicemia and
meningitis. S. suis has also been found to cause infection in humans
resulting in meningitis and endocarditis.

[0015]S. pneumoniae is a leading cause of bacterial pneumonia and
meningitis. S. agalactiae can develop neonatal sepsis, neonatal
meningitis and neonatal pneumonia. S. mutans plays a major role in tooth
decay, metabolizing sucrose to produce lactic acid and is equipped with
receptors for adhesion to the surface of teeth.

[0016]S. sanguinis typically found in dental plaque may gain entrance to
the blood stream and colonize in heart valves where it is the most common
cause of bacterial endocarditis.

[0017]In the past, conventional treatments included the use of antibiotics
that reduce symptoms, minimize transmission, and reduce the likelihood of
complications. Of particular interest, are the Streptococcus species that
result in strep throat. Treatment of strep throat generally consists of
oral or intramuscular injection of penicillin. Erythromycin is often
recommended for penicillin-allergic patients. In addition, other
antibiotics, such as amoxicillin, clindamycin, and oral cephalosporins
may also be recommended. Although symptoms typically subside within 4
days even without treatment, it is very important to start treatment
within 10 days of onset of symptoms, and to complete the full course of
antibiotics to prevent rheumatic fever.

[0018]As with any use of antibiotics, a major concern is development of
antibiotic resistant strains. In addition use of broad-spectrum
antibiotics has further drawbacks including vulnerability to human error,
additional cost and the like.

[0019]In one aspect, the present invention is directed to a method for the
production of antibodies or microbial adherence inhibitors for
administration to a patient suffering from strep throat to substantially
prevent the adherence of colony-forming immunogens or haptens in the
throat of the patient. Application of the antibodies should decrease the
colonization of the oropharynx, and therefore decrease symptoms of the
sore inflamed throat and ultimately decrease the need for antibiotics.

[0020]The method includes first inoculating female birds, in or about to
reach their egg laying age, with the particular target immunogen derived
from Streptococcus. Then after a period of time sufficient to permit the
production in the bird of antibody to the targeted immunogen, the eggs
laid by the birds are harvested. The total antibody-containing contents
of the eggs are separated from the shells and can be dried or used as a
liquid. The egg contents may be dried on a carrier material or mixed with
other additives or further purified. The dried or liquid separated egg
adherence inhibiting material may be stored or shipped for use when
needed.

[0021]Although application in individuals with strep throat is
specifically discussed, the present invention is also applicable to
development of other antibodies that can be used for the treatment of
other types of upper respiratory and lower respiratory illnesses and
illness caused by other species of Streptococcus.

[0022]The antibodies of the present invention are designed to target the
adhesion molecules of Streptococcus, and therefore will decrease their
ability to adhere to the membranes in the oropharynx and decrease their
ability to cause an infection in the area.

[0023]The antibodies of the present invention will be administered by any
conventional method, such as orally, by injection, by inhalation or the
like in a manner that permits substantially uniform distribution of the
antibodies throughout the target area or the throat of the patient.

[0024]The substantial prevention of colonization of a Streptococcus
species will ultimately permit substantial reduction or elimination of
the organism from the system. In addition, the antibodies may be
administered only once, or administered over some substantial period of
the illness and even after the symptoms have subsided. In addition, it is
expected that administration will vary depending on the individual and
severity of the illness.

[0025]The Streptococcus species mentioned herein possess the capability of
adhering to the affected membrane or organ in order to multiply and grow.
In the case of strep throat it is an individuals' throat or pharynx. The
antibodies of the present invention are therefore believed capable of
strongly interfering with adherence in a highly specific manner and, on a
cumulative basis, to thereby prevent the targeted organism from
multiplying, growing, and colonizing.

[0026]The most successfully colonizing microorganisms, bacteria, viruses,
and parasites, etc., have evolved a number of different types of
molecules, referred to as "adherens," on their surfaces which can very
tightly stick to one or more molecules that are part of the host's
various surfaces. The antibody of the present inventions are capable of
high specific activity which can very tightly bind to coat, cover, and
obliterate these "adherens" which attach themselves to their host with a
lock and key type of fit to very unique chemical structures.

[0027]The evidence seen in the animal models of the effectiveness of these
antibodies in clearing infection is encouraging. In addition, the science
behind these antibodies indicates that it will be very difficult for
bacteria known to cause this illness to develop resistance to this
approach. This will improve the effectiveness of this method of fighting
the bacteria.

[0028]The data that has been developed suggests that this approach will
clear the bacteria more quickly than conventional antibiotics. This will
decrease the incidence of seguelae from the illness.

[0029]The cost of this product will allow pricing in a way that will make
it unnecessary for a physician to perform a strep test. If this product
can be sold for the same price as a strep test costs and there is little
chance that a bacteria can develop resistance to the product then there
is no need to perform a strep test. With this model a physician will
merely prescribe this medicine to all people with a sore throat and then
treat those that fail clinically after the medicine is taken. This will
greatly reduce the use of antibiotics for this illness. In addition the
data that we have from animal models suggest that this will improve
clinical symptoms of the disease more rapidly than antibiotics, this will
make the patients happy about the use of this product in place of
antibiotics.

[0030]Marketing the product in this fashion will increase the patient
population that will be treated with this product to the entire 120
million people that visited their doctor for sore throats last year. This
will also decrease the use of antibiotics in the 50 million people that
were given antibiotics for sore throats last year. This will also
decrease the cost to the insurance companies. At this time they are
paying for the office visit, the strep test and the antibiotics. The
increase in resistance to antibiotics forces the insurance company to pay
for an additional visit and a second antibiotic. With implementation of
this treatment, great reductions in cost should be attained.